Investigator initiated Clinical Trial to Assess the Efficacy and Safety of proton pump inhibitor(Lansoprazole) in coronary artery disease undergoing percutaneous coronary intervention as compared with control.

A Single center, Randomised, Open , Investigator initiated Clinical Trial to Assess the Efficacy and Safety of proton pump inhibitor(Lansoprazole) in Patients with moderate bleeding risk and coronary artery disease undergoing percutaneous coronary intervention as compared with control.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008107

Enrollment

300

Registered

2023-01-13

Start date

2023-02-13

Completion date

Unknown

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1. medication : Lanston 2. capacity : 15mg 3. Number of times : QD 4. period : 6 month 5. Injection path : oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.19 years of age or older 2. patients diagnosed - stable angina - unstable angina - NSTEMI - STEMI 3. Those who are scheduled to receive or are taking double antiplatelet therapy including Aspirin after PCI 4.patients with low to moderate bleeding risk

Exclusion criteria

Exclusion criteria: 1. age < 19 years (vulnerable subjects) 2. known allergy to aspirin and clopidogrel 3. A person who is classified as a high-risk group according to the gastrointestinal risk assessment index 4. liver cirrhosis 5. known iron deficiency anemia 6. recent fibrinolytic therapy 7. active cancer 8. end-stage renal failure 9. life expectancy < 1 year 10. co-prescription of NSAIDs, corticosteroid and anticoagulant such as NOAC or warfarin 11. pregnancy or lactation 12. mentally or cognitively disabled people 13. not agree to participate in the study 14. mechanical ventilation with endotracheal intubation 15. persons related unequally to investigators (students and employees)

Design outcomes

Primary

Measure	Time frame
Combined variables of cardiovascular death, unnamed myocardial infarction, coronary artery revascularization, or ischemic stroke	—

Secondary

Measure	Time frame
; time from randomization to the first occurrence of gastroesophageal reflux disease, as evidenced by symptomatic, endoscopically confirmed erosive esophagitis	—

Countries

Korea, Republic of

Contacts

Public ContactHANA LEE

The Catholic University of Korea, Daejeon St. Mary's Hospital

modest86hana@naver.com+82-42-220-9869

Outcome results